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Clinical Study Manager

1 month ago
United States
Full-time
Senior
Program Manager
Project and Program Management
Apply Now
Penumbra

Penumbra

Penumbra Inc is a global healthcare company focused on innovating novel technologies to address challenging medical conditions in neuro and peripheral vascular markets. They design, develop, manufacture, and market medical devices for interventional th...

Health Care Providers & Services
1K-5K
Founded 2004
View All Jobs 30

Description

  • Develop and maintain clinical study timelines from startup through study completion, including databases, reports, abstracts, manuscripts, meetings, and regulatory submissions.
  • Drive the development, approval, and distribution of study documents, study tools, Case Report Forms, and study manuals for investigational sites and review committees.
  • Manage the collection, tracking, and distribution of regulatory documentation to support audit readiness at sites and headquarters.
  • Negotiate study budgets with sites, Core Labs, and other vendors.
  • Attend site visits, including site initiation, monitoring, and closeout visits, as needed.
  • Manage vendors, including Core Labs, and support vendor selection decisions.
  • Organize and lead Investigator Meetings and draft meeting content.
  • Monitor study progress, identify trends and issues, and implement corrective actions with the clinical team when needed.
  • Coordinate study startup and ongoing study management, including solutions for enrollment and protocol-related challenges.
  • Represent Clinical Affairs in cross-functional meetings and projects and communicate with internal stakeholders across Regulatory Affairs, Marketing, Legal, Customer Service, R&D, Finance, and Sales.
  • Support regulatory submissions, clinical study reports, and internal and external audit activities.
  • Mentor and train staff on protocols, good clinical practice, and departmental processes.
  • Evaluate, analyze, interpret, and present study data in clear, scientifically sound reports.
  • Forecast study timelines and budgets and help maintain trackers, dashboards, and project metrics.

Requirements

  • Bachelor's degree in Biological Sciences or a related field with 5+ years of experience, or an equivalent combination of education and experience.
  • 5+ years of relevant clinical trial experience in clinical/scientific research, nursing, or the medical device/pharmaceutical industry.
  • Field experience preferred.
  • Familiarity with laws, regulations, standards, and guidance governing clinical studies, including CFR and GCP/ICH requirements.
  • Proficiency with Microsoft Office, MS Project, EDC systems, study management systems, and vendor oversight.
  • Excellent oral, written, and interpersonal communication skills, with fluency in English and local language if different.
  • Ability to solve problems creatively, work on multiple projects simultaneously, and maintain keen attention to detail.
  • Working knowledge of medical terminology.
  • Excellent organizational skills with the ability to prioritize assignments while handling multiple projects simultaneously.
  • Willingness and ability to work on site, with business travel of 5% to 15% as needed.

Benefits

  • Annual base salary range of $123,000 to $170,000, depending on region and qualifications.
  • Competitive compensation package plus a benefits and equity program, when applicable.
  • Medical, dental, and vision insurance.
  • Life, AD&D, short-term disability, and long-term disability insurance.
  • 401(k) with employer match.
  • Paid parental leave.
  • Eleven paid company holidays per year.
  • Minimum of fifteen days of accrued vacation per year, increasing with tenure, plus paid sick time in compliance with applicable law.

Interested in this position?

Apply directly on the company website

Apply Now

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